BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial Formulation II) in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BIBW 2992 MA2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171715

1200.35

Details and patient eligibility

About

The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in comparison with the drinking solution and in comparison with the trial formulation II tablet, which was administered in phase II clinical trials and also partly in phase I trials.

Enrollment

22 patients

Sex

Male

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males according to a complete medical history, including a physical examination, vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram), and clinical laboratory tests
Age 21 to 55 years, inclusive
Body mass index 18.5 to 29.9 kg/m2, inclusive
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including drug allergy or its excipients)
Intake of drugs with a long half-life (> 24 hours) within one month prior to administration of the trial drug or during the trial
Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 10 days prior to first administration of the trial drug or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking within the in-house periods from 12 hours before until 25 hours after each administration of the trial drug
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration of the trial drug or during the trial)
Excessive physical activities (within one week prior to administration of the trial drug or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for Torsades de Points, e.g., heart failure, hypokalemia, family history of Long QT Syndrome

Exclusion criteria specific for this study:

Total bilirubin greater than 1.5 mg/dL
History of clinically relevant skin diseases, psoriasis or moderate/severe acne
Female gender
Male subjects who refuse to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or another medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intrauterine device, tubal ligation, hormonal contraceptive for at least two months, or diaphragm with spermicide